An observational study in Head and Neck Cancer, Dental Diseases and Osteoradionecrosis, sponsored by Wake Forest University Health Sciences. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Wake Forest University Health Sciences · Observational
The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.
This is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (RT) modalities with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-two participants were enrolled in the original study, ORARAD, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of RT. The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 202 is above the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
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This study will be offered to all living ORARAD participants approximately 7 years post-RT. Persons of all races and ethnicities and both females and males will thus be eligible for this study. Because participants will be drawn solely from the participants in the original ORARAD, the racial/ethnic composition of the study population at each center will be determined by the composition of those enrolled in the original ORARAD, which has been documented elsewhere. Since there is no evidence to suggest that dental outcomes in head and neck cancer patients are affected by gender, this expected unequal gender distribution of study participants will not affect the scientific validity of the study. Individuals who meet the eligibility criteria will be invited to participate in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dental Caries
Dental caries will be ascertained through the examination parameters outlined by NHANES, and the results of this examination with be used to calculate DMFS scores.
Time frame: 7 years
Bleeding on probing is documented (yes/no) (Periodontal Measure 1)
Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.
Time frame: 7 years
Clinical attachment loss (CAL) (Periodontal Measure 2)
Clinical attachment loss (CAL) measured in mm
Time frame: 7 years
Pocket depth (Periodontal Measure 3)
Pocket depth measured in mm
Time frame: 7 years
Tooth Loss
"Tooth loss" will be defined as a dental extraction that has been performed or recommended. Change in number of teeth throughout the duration of the study will be documented.
Time frame: 7 years
Exposed intraoral bone
Exposed intraoral bone is documented clinically by a trained clinical examiner and assessed based on a visual examination of the area, documenting the related tooth numbers or area and the following clinical signs: pain, swelling, induration, sequestrum, thin skin and/or beard loss (i.e. tissue hypoxia), evidence of pathologic fracture, tooth mobility, altered sensation in the affected area. The percentage of patients experiencing exposed bone, their recovery rates, and percent experiencing the signs will be calculated.
Time frame: 7 years
Salivary flow
Salivary flow is measured by the whole stimulated salivary flow rate. Changes in the rate and any association with other outcomes (e.g., caries) will be calculated.
Time frame: 7 years
Trismus measurements in mm
Change in mouth opening are documented in mm
Time frame: 7 years
7-year use of fluoride
Patients complete a questionnaire on use of fluoride (other than over the counter toothpaste), type, and frequency. Percent compliance with fluoride use and change in fluoride use will be calculated.
Time frame: 7 years
Compliance with brushing/flossing
Patients complete a questionnaire on frequency of brushing and flossing. Percent compliance with brushing and flossing guidelines (2x per day according to evidence-based professional guidelines) and change in compliance will be calculated.
Time frame: 7 years
Changes in RT-specific quality of life measures
Patients complete a likert scale questionnaire on 10 quality of life measures based on the European Organization for Research and Treatment of Cancer questionnaire. Ten individual question items were scored on a four-point scale indicating level of difficulty with daily tasks (1=not at all; 2=a little; 3=quite a bit; 4=very much).
Time frame: 7 years
Change in pain scores
Patients complete a likert scale questionnaire on pain levels during 8 daily activities rating their pain from no pain (0) to the worst pain imaginable (5) based on the European Organization for Research and Treatment of Cancer questionnaire.
Time frame: 7 years
Mortality
Time frame: 7 years
Cancer recurrence
Time frame: 7 years
Plan to share: Yes — PI will share deidentified data , no other documents, upon reasonable request
Supporting information: Study protocol
Time frame: immediately after publication, no expiration
Access criteria: send request to either Dr. Brennan (mike.brennan@atriumhealth.org) or Dr. Rajesh Lalla (lalla@uconn.edu).
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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